HH-120 Nasal Spray for Post-exposure Prevention of SARS-CoV-2

NCT05787418 | Enrolling By Invitation Phase 3 DMC

• 1 other identifier: HH120-NS311
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 2

Brief Summary

This study will assess the efficacy of HH-120 nasal spray in participants for the post-exposure prevention of SARS-CoV-2.

Conditions

COVID-19

Keywords

Severe Acute Respiratory Syndrome Coronavirus 2; Coronavirus disease 2019

Outcome Measures

Primary Outcomes (1)

• The incidence of symptomatic SARS-CoV-2 infection

  Incidence of participants with quantitative Real-Time polymerase chain reaction (qRT-PCR) confirmed SARS-CoV-2 infection and COVID-19 related symptom

  Up to 7 days

Secondary Outcomes (10)

• The incidence of SARS-CoV-2 infection

  Up to 7 days

• The changes in SARS-CoV-2 viral nucleic acid load

  Up to 7 days

• The change of viral load by qRT-PCR

  Up to 7 days

• Incidence and severity of adverse events

  Up to 21 days

• The incidence of symptomatic SARS-CoV-2 infection

  Up to 3 days

Study Arms (2)

HH-120 group

EXPERIMENTAL

HH-120 Nasal Spray

Drug: HH-120 Nasal Spray

Control group

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

HH-120 Nasal Spray DRUG

HH-120 nasal spray 8 times per day for 7 consecutive days

HH-120 group

Placebo DRUG

Placebo 8 times per day for 7 consecutive days

Control group

Eligibility Criteria

• Age: 12 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• to 85 years old.
• Participants with potential exposure to index patients (with known positive result of qRT-PCR or rapid antigen test \[RAT\]).
• Participants will be randomized no longer than 48 hours from the onset of the COVID-19 related symptom of the index patients.
• Participants with a negative RAT result within 2 hours prior to randomization.
• Fertile participants must agree to use a highly effective method of contraception.
• Participants being able and willing to provide informed consent prior to any study-specific procedure.

You may not qualify if:

• Those with high risk of cardiac events, or severe abnormal functions of liver, kidney, lung, brain and other organs and are deemed as unsuitable to participate in the study (except for those subjects with kidney failure but received regular dialysis, or those with liver dysfunction but stabilized after treatment evaluated by the evaluation of the investigators).
• Those comorbid with asthma.
• Those with a history of SARS-CoV-2 infection within 3 months prior to randomization.
• Those who has received any nasal spray or aerosol inhalation COVID-19 vaccine within 3 months prior to randomization.
• Those who experienced symptom of upper respiratory tract infection within 2 weeks prior to randomization, such as nasal congestion, sore throat, shortness of breath (dyspnea), cough, fatigue, fever, headache, etc.
• Known history of allergy or reaction to any component of the study drug formulation.
• Those who has received other treatment with anti-COVID-19 indication (within 1 month or 5 half-life period prior to randomization, whichever occurs first).
• Participants with nasal disease that is inconvenient or intolerant of nasal spray administration.
• Other reasons considered by the investigator to be unsuitable for the study.

Sponsors & Collaborators

• Huahui Health: lead

Study Sites (2)

Beijing Ditan Hospital, Capital Medical University

Beijing, 100000, China

Location

Huashan Hospital of Fudan University

Shanghai, 200000, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: March 28, 2023
• Study Start: March 31, 2023
• Primary Completion: December 31, 2025
• Study Completion: April 1, 2026
• Last Updated: October 10, 2024

Record last verified: 2024-10

Locations

CN (2)